C F M TECHNOLOGIES INC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Curette, Ear (JYG) (8) Otoscope (ERA) (6)

Premarket Exempt

No Yes

Clear

ENT Pocket Light - 00850013958009 Catalog Number : ENT-PL2-BK

Device Description : ENT Pocket Light - Basic Set Otoscope set with disposable specula and nasal head.

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

ENT Pocket Light - 00850013958016 Catalog Number : ENT-PL2-BL

Device Description : ENT Pocket Light - Basic Set Otoscope set with disposable specula and nasal head.

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

ENT POCKET LIGHT - 00850013958023 Catalog Number : PL3-BK

Device Description : Deluxe ENT Pocket Light Set Otoscope set with reusable ear curettes and nasal head. Black

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : JYG, ERA

Prescription Use : No

Device Count : 1

ENT POCKET LIGHT - 00850013958030 Catalog Number : PL3-BL

Device Description : Deluxe ENT Pocket Light Set Otoscope set with reusable ear curettes and nasal head. Blue

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : JYG, ERA

Prescription Use : No

Device Count : 1

ENT POCKET LIGHT - 00850013958047 Catalog Number : PL4-BK

Device Description : Deluxe ENT Pocket Light Set Otoscope set with reusable and single ear curettes Deluxe ENT Pocket Light Set Otoscope set with reusable and single ear curettes and nasal head. Black

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : JYG, ERA

Prescription Use : No

Device Count : 1

ENT POCKET LIGHT - 00850013958054 Catalog Number : PL4-BL

Device Description : Deluxe ENT Pocket Light Set Otoscope set with reusable and single-use ear curet Deluxe ENT Pocket Light Set Otoscope set with reusable and single-use ear curettes and nasal head. Blue

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : JYG, ERA

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958061 Catalog Number : CM1-BK

Device Description : Cerumen Management Set with reusable curettes.

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958078 Catalog Number : CM1-BL

Device Description : Cerumen Management Set with reusable curettes. Blue

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958085 Catalog Number : CM2-BK

Device Description : Cerumen Management Set with reusable and single-use curettes.

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : No

Device Count : 1

CFM Technologies - 00850013958092 Catalog Number : CM2-BL

Device Description : Cerumen Management Set with reusable and single-use curettes.

Device Class : 1

Duns Number: 040748944

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : No

Device Count : 1

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